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# FDA Refuses to File Inbrija NDA
- URL: https://www.fdaweb.com/fda-refuses-to-file-inbrija-nda/
- Published: 2017-08-29T12:00:00.000Z
- Updated: 2026-09-14T22:45:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139491

FDA has sent Acorda Therapeutics a Refusal to File letter for the NDA for its Inbrija (levodopa inhalation powder), an investigational treatment for symptoms of off periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. The company [reports](http://ir.acorda.com/investors/investor-news/investor-news-details/2017/Acorda-Receives-Refusal-to-File-Letter-from-FDA-for-INBRIJA-CVT-301-levodopa-inhalation-powder-New-Drug-Application/default.aspx?ref=fdaweb.com) that FDA found that Acorda’s 6/26 NDA was not sufficiently complete to permit a substantive review. Two reasons were specified for the letter: **(1)** the date when the manufacturing site would be ready for inspection, and **(2)** a question about the submission of the drug master production record.

Acorda says it will seek a Type A meeting with FDA to respond to the issues and to seek additional clarification on what additional information will be required. It says the agency has not requested or recommended additional clinical efficacy or safety studies.